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Samsung Bioepis Co., Ltd.

http://www.samsungbioepis.com/

Latest From Samsung Bioepis Co., Ltd.

Still ‘Work To Be Done’ After Ranibizumab Approval, Says Samsung Bioepis

Samsung Bioepis recently broke new ground with the first US approval for a biosimilar with ophthalmic indications. But, senior vice-president and development division leader Kyung-Ah Kim tells Generics Bulletin, there remains work to be done to ensure that ophthalmic biosimilars can meet their full potential.

Biosimilars Strategy

US FDA’s October Outlook Includes Psoriasis Blockbuster Hopeful, Ophthalmology And Orphans

User fee goal dates are coming up in October for more than 15 applications, according to the Pink Sheet’s US FDA Performance Tracker.

Drug Review Advisory Committees

US Biosimilars Strength Rides On The Wings Of Oncology Launches

Herceptin, Avastin and Rituxan biosimilars have achieved notable market penetration, outpacing other biosimilar launches and contributing to lower drug spending, according to a report from Amgen.

Biosimilars Pricing Strategies

FDA Approves First Ophthalmic Biosimilar With Samsung Bioepis’ Lucentis Rival

Samsung Bioepis has celebrated the FDA’s first ever approval of an ophthalmic biosimilar with its endorsement of the firm’s Byooviz ranibizumab rival to Lucentis. The firm has also signaled a surprising expected launch date in the US, as well as offering expectations for launch in Europe where the biosimilar was also recently approved.

Biosimilars Approvals
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Company Information

  • Industry
  • Pharmaceuticals
  • Biotechnology
    • Large Molecule
  • Other Names / Subsidiaries
    • Samsung Biologics
    • Samsung Bioepis JV
    • Samsung Bioepis BR Pharmaceutical LTDA
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